(252 days)
Alpha Dent Implants Dental Implants System is intended for surgical placement in the maxillary and/or the mandibular arch, to support crowns, bridges, or over dentulous patients. It is intended to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. The System is intended to be used in either single tooth or multiple teeth applications. The prostheses can be screw or cement retained to the abutment.
The Alpha Dent Implants Dental Implants System is indicated also, for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The Alpha Dent Implant Active Conus (IAK), Implant Classic Conus (ICK), Implant Active Bio (IAB) Dental Implants System consists of one or two stage Endosseous form dental implants, with same platform of implant/prosthetics abutments connection- internal hexagon for anti-rotation and internal cone, and It is intended to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.
The Alpha Dent Implants Dental Implants System is a medical device intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous patients. It aims to provide support for prosthetic devices (artificial teeth) and restore chewing function. The system is designed for single-tooth or multiple-teeth applications, with prostheses that can be screw or cement-retained to the abutment. It is also indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The device's acceptance criteria and the study that proves it meets these criteria are detailed below:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Alpha Dent Implants Dental Implants System are primarily based on demonstrating substantial equivalence to predicate devices (K181138 and K180968) in terms of intended use, materials, performance, and safety. The performance criteria are derived from relevant international standards and the results of non-clinical testing.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance and Evidence |
|---|---|---|
| Intended Use | The device's intended use and indications for use should be substantially equivalent to previously cleared predicate devices. | The subject device's intended use and indications for use are previously cleared by FDA for the reference device K180968 (Alpha Dent Dental Implants Ltd) and are stated to be the same as the primary predicate K181138 (IS-III active System, Neobiotech Co., Ltd). |
| Materials | Implants and prosthetic components must be manufactured from medical-grade materials that comply with relevant standards. | Implants and abutments are manufactured from Titanium alloy (Ti 6Al 4V ELI) complying with ASTM F 136 Standard. This material is consistent with the predicate devices (Ti Grade 5 (Ti6AL4V-ELI) ASTM F136-13 for K180968 and Ti CP4 of ASTM F67 for K181138, though the subject device uses a higher grade Ti alloy). |
| Biocompatibility | The device must demonstrate biocompatibility for its intended use, in accordance with established biological evaluation standards. | Biocompatibility evaluation was conducted in accordance with ISO 10993-1 and FDA guidance. All biological endpoints were met, establishing the device as biocompatible. SEM and Surface analysis (EDS) after the anodize process demonstrated morphology and cleanliness. |
| Sterilization & Packaging | The device must be provided sterile (implants) with a minimum sterility assurance level (SAL) of 10⁻⁶, and packaging must maintain sterility for the specified shelf life. Non-sterile components (abutments) must have validated sterilization instructions for the end-user. | Implants are packaged in a clean room (ISO CLASS 7) and provided with a SAL of 10⁻⁶, validated per ANSI/AAMI/ISO 11137-1 and EN ISO 11137-2. Accelerated aging per ASTM-F-1980 was applied to substantiate a 5-year shelf life, with a real-time study ongoing. Abutments are supplied non-sterile, and moist heat sterilization for end-users was validated per ANSI/AAMI/ISO 17665-1, demonstrating a 6-log reduction of Geobacillus stearothermophilus. |
| Pyrogenicity | The device must meet pyrogen limit specifications. | LAL Endotoxin Analysis demonstrated pyrogenicity met specifications, with a testing limit of 20 EU/device, based on USP . |
| Mechanical Performance | The implants must withstand dynamic fatigue loads per ISO 14801, demonstrating sufficient mechanical strength and durability. Performance should be comparable to the predicate device. For prosthetic components, the implant-abutment connection design and general shape should be similar to recognized predicate devices. The thread type variation for internal thread should not affect structural performance and offer same pitch design. | Static and dynamic compression performance tests were conducted per ISO 14801. The worst-case scenario (smallest diameter, longest implant, 25° abutment) was selected. The measured fatigue limits for Alpha Dent implants were similar to those of the predicate device Neobiotech (K181138) (metal dental implants with a diameter of 3.5 mm). The run-out bending moment was within similar values. The implant/abutment connection design, general shape, and dimensions are compared to predicate K180968. The difference in internal thread type (M1.80-6H vs 1-72 UNF 2B) was deemed not to affect structural performance as both have identical outer diameter (1.80 mm) and same pitch design. |
| Design/Technological Characteristics | The device's technological characteristics, including implant/abutment connection design, surface treatment, general shape, and dimensions, should be comparable to predicate devices. | The implant/abutment connection design (internal hexagon for anti-rotation and internal cone) is stated to be the same as the primary predicate (K181138). The surface treatment (anodized layer), general shape, and dimensions are substantially equivalent to the reference predicate (K180968). While there is a slight difference in design and dimensions between the primary predicate and the subject device, and a minor difference in internal thread type, these were considered not to affect structural performance. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific "sample size" in terms of number of devices for each non-clinical test (e.g., how many implants were subjected to fatigue testing). It generally refers to "the implant used in the testing was the smallest in diameter and the longest in length available with this system of implants," indicating a worst-case selection for mechanical performance.
The data provenance is from non-clinical bench testing conducted by Alpha Dent Implants GmbH, not from human or animal subjects. Therefore, there is no information on country of origin of data, or whether it was retrospective or prospective in the sense of clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable. The "test set" in this context refers to non-clinical bench testing data and engineering analysis, not clinical data requiring expert review for ground truth establishment. Equivalence is established through comparison to predicate devices and adherence to international standards.
4. Adjudication Method for the Test Set
This question is not applicable. There was no "test set" of clinical cases requiring adjudication by experts. The substantiation relies on engineering judgment, comparison to predicate devices, and demonstrated compliance with recognized standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. The document explicitly states: "No clinical studies were performed." This is a 510(k) submission primarily relying on substantial equivalence to legally marketed predicate devices through non-clinical performance testing and comparative analysis of design and materials.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This question is not applicable. The Alpha Dent Implants Dental Implants System is a physical medical device (dental implants and associated prosthetic components), not an AI algorithm or software. Therefore, there is no "standalone" algorithm performance to assess.
7. The Type of Ground Truth Used
The "ground truth" for demonstrating the safety and effectiveness of the device is established by:
- Substantial Equivalence to Predicate Devices: Comparing the new device's intended use, technological characteristics (design, materials, surface treatment), and performance data to those of one or more legally marketed predicate devices (K181138 and K180968) that have already been determined safe and effective.
- Adherence to Recognized International Standards: Compliance with standards such as ASTM F 136 (material), ISO 10993-1 (biocompatibility), ANSI/AAMI/ISO 11137-1 and EN ISO 11137-2 (sterilization), USP (pyrogenicity), ASTM-F-1980 (accelerated aging/shelf life), and ISO 14801 (dynamic fatigue test for implants).
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" in the context of this device submission, as it is a physical medical device and not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as point 8.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.